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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
PF-07104091 is an investigational compound. Its safety and efficacy have not been established.
PF-07220060 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Argentina, Brazil, Bulgaria, China, Czechia, Mexico, South Africa, Spain
EXPERIMENTAL: Part 1 Dose Escalation - Dose Level 1
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
DRUG: PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
EXPERIMENTAL: Part 1 Dose Escalation - Dose Level 2
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
DRUG: PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
EXPERIMENTAL: Part 1 Dose Escalation - Dose Level 3
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
DRUG: PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
EXPERIMENTAL: Part 1 Dose Escalation - Dose Level 4
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
DRUG: PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
EXPERIMENTAL: Part 1 Dose Escalation - Dose Level 5
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
DRUG: PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
EXPERIMENTAL: Part 2A
PF-07220060 + PF-07104091 + Fulvestrant (ER+/HER2- Breast Cancer with at least 1 prior systemic therapy for advanced or metastatic disease, including CDK4/6 inhibitor treatment and Endocrine Therapy)
DRUG: PF-07104091 + PF-07220060 + fulvestrant dose expansion
PF-07104091 and PF-07220060 will be administered orally in combination with fulvestrant
EXPERIMENTAL: Part 2B
PF-07220060 + PF-07104091 + Fulvestrant (ER+/HER2- Breast Cancer with at least 1 prior endocrine therapy and up to 1 prior line of chemotherapy for advanced or metastatic disease and no prior treatment with any CDK4/6 inhibitor for advanced disease)
DRUG: PF-07104091 + PF-07220060 + fulvestrant dose expansion
PF-07104091 and PF-07220060 will be administered orally in combination with fulvestrant
EXPERIMENTAL: Part 2C
PF-07220060 + PF-07104091 + Letrozole (ER+/HER2- Breast Cancer with no prior treatment with any CDK4/6 inhibitor for advanced disease)
DRUG: PF-07104091 + PF-07220060 + letrozole dose expansion
PF-07104091 and PF-07220060 will be administered orally in combination with letrozole
EXPERIMENTAL: Part 1 Dose Escalation - Dose Level 6
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
DRUG: PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
EXPERIMENTAL: Part 1 Dose Escalation - Dose Level 7
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
DRUG: PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
EXPERIMENTAL: Part 1 Dose Escalation - Dose Level 8
PF-07220060 + PF-07104091 dose escalation (Breast Cancer or solid tumors)
DRUG: PF-07220060 + PF-07104091 combination dose escalation
PF-07104091 and PF-07220060 will be administered orally
Inclusion Criteria
Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle
Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level
Cycle 1 (28 days)
Number of participants with treatment emergent adverse events (AEs)
From baseline until end of study treatment or study completion (approximately 2 years)
Incidence of participants with clinical laboratory abnormalities
From baseline until end of study treatment or study completion (approximately 2 years)
Number of participants with vital signs abnormalities
From baseline until end of study treatment or study completion (approximately 2 years)
Number of participants with corrected QT (QTc) interval
Determine the effect of the drug on QT prolongation. The number and percentage of participants who experienced QT interval prolongation will be summarized by dose level
From baseline until end of study treatment or study completion (approximately 2 years)
Maximum plasma concentration (Cmax) of PF-07220060 and PF-07104091 together after a single dose and multiple dose
Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Time to maximum plasma concentration (Tmax) of PF-07220060 and PF-07104091 together after a single dose and multiple dose
Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07220060 and PF-07104091 together
Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Objective response rate (ORR) of PF-07220060 and PF-07104091 together in dose escalation and together in combination with fulvestrant or letrozole
Percentage of participants with a best ORR of complete response (CR) or partial response (PR) using RECIST 1.
From baseline through disease progression or study completion (approximately 2 years)
To evaluate the preliminary antitumor activity of PF-07220060 and PF-07104091 together in dose escalation and together in combination with fulvestrant or letrozole by time to event endpoints
Time from first assessment of event endpoint to last assessment of using RECIST 1.1
From baseline through time to event on study or study completion (approximately 2 years)
Duration of Response (DoR) of PF-07220060 and PF-07104091 together in dose escalation and together in combination with fulvestrant or letrozole
DoR is defined as the time from first documentation of CR or PR to date of first documentation of progressive disease/pharmacodynamic (PD) or death due to any cause, whichever occurs first
From baseline through time to event on study or study completion (approximately 2 years)
Progression-Free Survival (PFS) of PF-07220060 and PF-07104091 together in dose escalation and together in combination with fulvestrant or letrozole
PFS is defined as time from start date of treatment to the date of first documentation of PD or death due to any cause
From baseline through time to event on study or study completion (approximately 2 years)
Time to Progression (TTP) of PF-07220060 and PF-07104091 together in dose escalation and together in combination with fulvestrant or letrozole
TTP is defined as the time from start date of treatment to the date of the first documentation of PD
From baseline through time to event on study or study completion (approximately 2 years)
240
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: